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Clostridioides Difficile Infection

5
Pipeline Programs
7
Companies
10
Clinical Trials
3 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
1
2
0
1
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
2100%
+ 8 programs with unclassified modality

Competitive Landscape

7 companies ranked by most advanced pipeline stage

Human BioSciences
Human BioSciencesWV - Martinsburg
2 programs
1
RidinilazolePhase 3Small Molecule1 trial
FMTN/A1 trial
Active Trials
NCT07120490Not Yet Recruiting424Est. Apr 2027
NCT04802837Terminated2Est. Sep 2022
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
2 programs
1
1
AZD5148Phase 21 trial
AZD5148Phase 11 trial
Active Trials
NCT06639997Completed16Est. Dec 2025
NCT07285213Recruiting230Est. Jan 2028
Acurx Pharmaceuticals
Acurx PharmaceuticalsSTATEN ISLAND, NY
1 program
1
ibezapolstatPhase 2Small Molecule2 trials
Active Trials
NCT07513285Not Yet Recruiting20Est. Nov 2027
NCT04247542Completed53Est. Nov 2023
Exeliom Biosciences
Exeliom BiosciencesFrance - Dijon
1 program
1
EXL01Phase 1/21 trial
Active Trials
NCT06306014Recruiting56Est. Jan 2027
Seres Therapeutics
Seres TherapeuticsCAMBRIDGE, MA
2 programs
SER-109N/A1 trial
SER-109PHASE_31 trial
Active Trials
NCT02437500Approved For Marketing
NCT03183141Completed263Est. Apr 2022
Crestone
CrestoneCO - Boulder
1 program
CRS3123PHASE_2
Lumen Bioscience
Lumen BioscienceWA - Seattle
1 program
LMN-201PHASE_2_31 trial
Active Trials
NCT05330182Recruiting375Est. Dec 2027

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
Human BioSciencesRidinilazole
Seres TherapeuticsSER-109
Lumen BioscienceLMN-201
Acurx Pharmaceuticalsibezapolstat
AstraZenecaAZD5148
Acurx Pharmaceuticalsibezapolstat
Exeliom BiosciencesEXL01
AstraZenecaAZD5148
Human BioSciencesFMT

Clinical Trials (10)

Total enrollment: 1,439 patients across 10 trials

NCT04802837Human BioSciencesRidinilazole

Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects

Start: May 2021Est. completion: Sep 20222 patients
Phase 3Terminated
NCT03183141Seres TherapeuticsSER-109

ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection

Start: Oct 2017Est. completion: Apr 2022263 patients
Phase 3Completed
NCT05330182Lumen BioscienceLMN-201

LMN-201 for Prevention of C. Difficile Infection Recurrence

Start: Aug 2024Est. completion: Dec 2027375 patients
Phase 2/3Recruiting
NCT07513285Acurx Pharmaceuticalsibezapolstat

ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection

Start: Aug 2026Est. completion: Nov 202720 patients
Phase 2Not Yet Recruiting
NCT07285213AstraZenecaAZD5148

Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody

Start: Dec 2025Est. completion: Jan 2028230 patients
Phase 2Recruiting
NCT04247542Acurx Pharmaceuticalsibezapolstat

ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection

Start: Mar 2020Est. completion: Nov 202353 patients
Phase 2Completed
NCT06306014Exeliom BiosciencesEXL01

Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients

Start: May 2024Est. completion: Jan 202756 patients
Phase 1/2Recruiting
NCT06639997AstraZenecaAZD5148

Safety and Tolerability of AZD5148 in Japanese Participants

Start: Oct 2024Est. completion: Dec 202516 patients
Phase 1Completed
NCT02437500Seres TherapeuticsSER-109

Expanded Access Program of SER-109 in the Treatment of Adults With Recurrent Clostridioides Difficile Infection (RCDI)

N/AApproved For Marketing
NCT07120490Human BioSciencesFMT

STOP-CDI: Efficacy of Fecal Microbiota Transplantation vs Fidaxomicin vs Vancomycin in Treating and Preventing Relapse of Clostridioides Difficile Infection

Start: Oct 2025Est. completion: Apr 2027424 patients
N/ANot Yet Recruiting

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
3 actively recruiting trials targeting 1,439 patients
7 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.